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1.
J Cancer Surviv ; 18(1): 42-52, 2024 02.
Article in English | MEDLINE | ID: mdl-38294598

ABSTRACT

For the past 30 years, the University of Minnesota's Cancer Survivorship Program has been dedicated to providing exceptional care to patients who have lived the cancer experience. Our model is consultative, risk-stratified, and oncologist-led but executed predominately by advanced practice providers. Care is personalized and serves three survivor populations: children, adults, and patients who received BMT with over 500 new patients evaluated annually. As guidelines and survivorship standards have changed, our clinical programs have evolved from a focus on survivorship care plans to supportive care. The program offers a wide range of supportive services from acupuncture to nutritional services as well as several educational programs for patients. The program has a strong research legacy, notably as the birthplace of research that led to the Children's Oncology Group Guidelines as well as advancements in cardio-oncology and frailty after bone marrow transplantation. In 2021, we hosted the first annual Survivorship Research Forum, providing the opportunity and space for experts across disciplines to exchange ideas on a broad range of survivorship topics not possible at other national cancer-related conferences. With successes and challenges, we have identified opportunities for growth as our program continues to evolve and grow in our goal to improve cancer outcomes along a wide spectrum of physical, emotional, functional, and social dimensions. IMPLICATIONS FOR CANCER SURVIVORS: The University of Minnesota Cancer Survivorship Program provides care, education, and research opportunities for patients across the cancer continuum.


Subject(s)
Cancer Survivors , Neoplasms , Adult , Child , Humans , Survivorship , Cancer Survivors/psychology , Survivors , Neoplasms/therapy , Educational Status
3.
BMJ Case Rep ; 16(5)2023 May 23.
Article in English | MEDLINE | ID: mdl-37221007

ABSTRACT

Primary signet-ring cell carcinoma of the uterus is rare and requires exclusion of possible metastatic tumour to the uterus. We report a case of a woman in her 70s who underwent hysteroscopy and a polypectomy for a polyp arising from the uterine wall. On histological examination, malignant cells with signet-ring cell morphology were found within the fragments of endometrial tissue. Immunohistochemical studies indicated a metastatic adenocarcinoma possibly from the gastrointestinal tract. Additional radiological investigations revealed a possible primary gastric tumour, which was further confirmed on subsequent biopsies. This case illustrates that gastric carcinomas can rarely metastasise to the endometrium and highlights the importance of clinical correlation in arriving at the final diagnosis.


Subject(s)
Adenocarcinoma , Carcinoma, Signet Ring Cell , Polyps , Stomach Neoplasms , Female , Humans , Uterus , Epithelium
4.
Cureus ; 15(12): e51221, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38283500

ABSTRACT

A colovaginal fistula (CVF) is an abnormal epithelialized connection between the colon and the vagina. It is a rare complication following gynaecology surgery and can significantly affect patients' quality of life. CVFs are commonly associated with diverticular disease and are usually seen in patients with a previous hysterectomy. We report an uncommon case of postsurgical CVF following vaginal hysterectomy with mesh-augmented pelvic floor repair, which was unrelated to diverticulitis. The patient was successfully managed by a multidisciplinary team with staged surgery.

5.
Semin Oncol Nurs ; 37(3): 151162, 2021 06.
Article in English | MEDLINE | ID: mdl-34148742

ABSTRACT

OBJECTIVES: Phase 1 clinical trials are essential in the development of novel therapies for childhood cancers. Children with cancer can participate in phase 1 clinical trials when no known curative therapy remains. Understanding the experiences of children and their families in these clinical trials can help ensure that participation supports the children's and parents' well-being. This article explores the specific aspects of pediatric oncology phase 1 trials that parents found particularly challenging. DATA SOURCES: This qualitative, empirical phenomenology study considered 11 parents' experiences during the time their child with cancer participated in a phase 1 clinical trial. The primary study results were previously reported. This article reports parents' insights into the processes and procedures that occurred as part of participation in a pediatric oncology phase 1 trial. CONCLUSION: Parents' experiences during the phase 1 clinical trials were primarily positive. However, data analysis revealed five aspects of these trials that were challenging for families: learning about clinical trials, being referred to another institution, research-only procedures, adhering to trial requirements, and oral medications. IMPLICATIONS FOR NURSING PRACTICE: Although experiences during phase 1 clinical trials were positive overall, opportunities to enhance children's and parents' experiences warrant attention. Enhancing the education provided to families during recruitment and minimizing the logistical burdens associated with trial requirements through care coordination may alleviate challenges experienced by children and parents.


Subject(s)
Neoplasms , Parents , Child , Humans , Medical Oncology , Neoplasms/therapy , Professional-Family Relations , Qualitative Research
6.
Reprod Sci ; 28(11): 3164-3170, 2021 11.
Article in English | MEDLINE | ID: mdl-34076868

ABSTRACT

Use of GnRH antagonists in IVF stimulation protocols shortens controlled ovarian hyperstimulation (COH) and reduces the risk of ovarian hyperstimulation syndrome (OHSS). However, profound reduction in LH levels has been associated with use of GnRH antagonists. This study aims to determine if LH suppression during GnRH antagonist cycles results in poorer IVF outcomes. This was a prospective pilot longitudinal study where serum LH levels were measured on day 2/3 of the menstrual cycle before COH, 1/2 days following institution of GnRH antagonist and at the day of ovulation trigger. A threshold of LH <0.5 IU/L was used to define profound LH suppression. Data on IVF outcomes was collected. Logistic regression analysis was used to investigate risk factors associated with LH suppression following GnRH antagonist IVF treatment. Ninety-one eligible women were recruited. Women underwent a standard antagonist cycle with Puregon 200u and Ganirelix. No participant had LH <0.5 IU/L prior to GnRH antagonist treatment, and 27 participants (29.7%) had significant LH suppression at either time point. Predictors of profound LH suppression following GnRH antagonist treatment identified (P < 0.20) were age (OR = 0.80, P = 0.013), no previous ovulation induction (OR = 0.26, P = 0.033) and previous GnRH antagonist IVF cycle (OR = 4.32, P = 0.125). Numbers of oocytes, embryos and ongoing pregnancy rates at 12 weeks gestation in patients with and without LH suppression did not differ significantly. We found associations between clinical characteristics and risk of profound LH suppression in women undergoing GnRH antagonist IVF cycles, but no significant differences in IVF and pregnancy outcomes between women with and without significant LH suppression.


Subject(s)
Fertilization in Vitro/methods , Hormone Antagonists/pharmacology , Luteinizing Hormone/antagonists & inhibitors , Luteinizing Hormone/blood , Pregnancy Outcome/epidemiology , Adult , Female , Follicle Stimulating Hormone, Human/pharmacology , Follow-Up Studies , Gonadotropin-Releasing Hormone/analogs & derivatives , Gonadotropin-Releasing Hormone/pharmacology , Humans , Longitudinal Studies , Pilot Projects , Pregnancy , Prospective Studies , Recombinant Proteins/pharmacology , Treatment Outcome , Young Adult
7.
Matern Child Health J ; 25(1): 38-41, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33222027

ABSTRACT

INTRODUCTION: Rapid dissemination of findings regarding the Coronavirus Disease 2019 (COVID-19) and its potential effects on pregnancy is crucial to support understanding and development of recommendations for optimization of obstetrics care. However, much of the current studies published are in the form of case reports or case series which can be prone to biases. Other factors also further complicate attempts to analyze data accurately. Hence, this evaluation hopes to highlight some of these problems and provide suggestions to help clinicians mitigate and make reasonable conclusions when reading the abundant yet limited body of evidence when furthering their research efforts. METHODS: Studies regarding COVID-19 and pregnancy were searched on databases such as PubMed, EMBASE, Scopus, the Cochrane Library. Manual search of references of select articles were also undertaken. Apart from summarizing study limitations identified by authors, the characteristics of current literature and systematic reviews were also evaluated to identify potential factors affecting accuracy of subsequent analysis. RESULTS: Factors such as innate biasness in study design of current literature, duplicate reporting, differing inclusion criteria of systematic reviews, scarce data, inadequate follow-up period and limitations of systematic reviews have been shown to hinder the ability for accurate data extrapolation. DISCUSSION: Unless additional studies are conducted in identified areas of data scarcity and a common list of factors affecting accuracy of data analysis are taken into account when developing recommendations, discrepancies will continue to arise and accurate data analysis and valid systematic reviews will be precluded.


Subject(s)
COVID-19/prevention & control , Data Accuracy , Guidelines as Topic , Maternal Health Services/standards , Pregnancy Complications, Infectious/prevention & control , Research Design/standards , Systematic Reviews as Topic/standards , Adult , Female , Humans , Pregnancy , SARS-CoV-2
11.
MedEdPublish (2016) ; 9: 93, 2020.
Article in English | MEDLINE | ID: mdl-38058908

ABSTRACT

This article was migrated. The article was marked as recommended. Background The experience of teaching students from multiple medical schools with separate curriculums and learning ethos within a single healthcare institution is not well-documented in literature. Objective We aimed to identify the benefits and challenges of having students from three medical schools train within one department from the clinical tutors' and medical students' viewpoint. Methods This was a cross-sectional study at KK Women's and Children's Hospital (KKH). A survey was conducted on clinical tutors and students from three medical schools for their viewpoints on a 5-point Likert scale. Results 91 of 100 (91%) students and 51 of 60 (85%) tutors returned the survey. 95.6% of students and 94.1% of tutors agreed that it was important for KKH to be involved in the teaching of all three medical schools. 83.5% of students and 76.5% of tutors believed they would benefit from shared teaching and learning materials. 84.3% of tutors and 83.6% of students agreed that they could be exposed to new teaching methods while 84.7% of students and 72.5% of tutors believed that opportunities to collaborate between schools would arise. However, 25 (49%) tutors and 58 (63.7%) students believed that there may be limited supervision. Students (60.4%) and tutors (56.9%) alike felt that there would be a lack of learning space. Conclusion Both students and tutors believed that it was important for medical students for the department in KKH to be involved in the teaching of all three medical schools. Benefits perceived included shared teaching and learning resources, exposure to new teaching methods and opportunity for collaboration across medical schools. Through careful planning of rotations and supportive leadership, hospitals can optimise teaching capabilities allowing students and tutors to benefit from advantages of teaching of students from multiple medical schools.

13.
J Adolesc Young Adult Oncol ; 8(4): 442-450, 2019 08.
Article in English | MEDLINE | ID: mdl-28853979

ABSTRACT

Purpose: Many adult survivors of childhood cancer are at high-risk of developing cardiovascular disease. Cancer therapy may cause damage to the vascular endothelium, thereby initiating atherosclerosis. Atorvastatin has been shown to improve endothelial function independent of reducing cholesterol, as well as reduce/slow arterial stiffness and thickening, yet has never been studied in childhood cancer survivors (CCS). Methods: Twenty-seven young adult (age 26.8 ± 6.2 years) survivors of childhood acute lymphoblastic leukemia or Non-Hodgkin's lymphoma were randomly assigned (1:1) 40 mg/day of atorvastatin or placebo for 6 months. Brachial artery flow-mediated dilation (FMD), small artery reactive hyperemia index (RHI), arterial stiffness, and carotid artery elasticity/thickness were assessed. Results: Fifteen participants completed the trial. No significant treatment effect for any vascular outcomes was observed at 6 months; however, a significant decrease in peak FMD (-3.0 [95% confidence interval [CI]: -5.3, -0.7]) and a trending significant decrease in RHI (-0.3 [95% CI: -0.62, 0.01]) was observed in the placebo group, resulting in a trend toward a treatment effects (p < 0.10). No effect on arterial stiffness, carotid arterial elasticity, or thickness was observed. Conclusion: Six months of atorvastatin treatment did not improve endothelial function or arterial stiffness in young adult CCS. While a trend toward an improvement in endothelial function was present, findings should be interpreted with caution owing to the small number of evaluable participants and subsequent lack of sufficient power. Further research in a larger sample size is needed to fully elucidate the effects of atorvastatin on vascular function. Trial registered at clinicaltrials.gov as NCT01733953.


Subject(s)
Atherosclerosis/prevention & control , Atorvastatin/therapeutic use , Cancer Survivors , Carotid Arteries/drug effects , Endothelium, Vascular/drug effects , Lymphoma, Non-Hodgkin/pathology , Precursor Cell Lymphoblastic Leukemia-Lymphoma/pathology , Adolescent , Adult , Atherosclerosis/etiology , Atherosclerosis/pathology , Carotid Arteries/pathology , Child , Child, Preschool , Double-Blind Method , Endothelium, Vascular/pathology , Female , Follow-Up Studies , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Male , Pilot Projects , Prognosis , Vascular Stiffness/drug effects , Young Adult
14.
Singapore Med J ; 57(5): 233-7, 2016 May.
Article in English | MEDLINE | ID: mdl-27211310

ABSTRACT

INTRODUCTION: This study aimed to describe the planning, development and evaluation of the success of the first nationwide, resident-led, large-group teaching programme for medical students - the Singapore Health Services Student Internship Programme (SIP) Bootcamp. METHODS: This was an initial feasibility study evaluating a half-day teaching boot camp initiated, developed and conducted by the resident educators. A three-month preparation period was required to set up an education subcommittee, liaise with medical student leaders, recruit resident educators, meet all the stakeholders and conduct the boot camp. During the SIP Bootcamp, resident educators conducted clinical case presentations using a question-and-answer format. Audience participation was strongly encouraged. A 15-item questionnaire was distributed to assess the participants' learning experience and the resident educators' teaching performance using a five-point Likert scale. RESULTS: Overall, 94.8% (n = 110) of the 116 respondents agreed that the teaching sessions were of high quality and content was relevant to their training. The resident educators appeared well-informed (96.6%, n = 112) and enthusiastic about their respective topics (98.3%, n = 114). However, a few students (9.5%, n = 11) felt that the audio-visual aids and handouts could be improved to better aid their learning process. CONCLUSION: This teaching boot camp for medical students was the first of its kind in Singapore and feedback from medical students showed that it was well-received. Further research using different teaching methods, including small-group discussions and surgical practical sessions by resident educators from different specialties, would be of great value to students.


Subject(s)
Education, Medical/organization & administration , Internship and Residency , Schools, Medical , Students, Medical , Clinical Competence , Curriculum , Education, Medical/methods , Feasibility Studies , Humans , Singapore , Surveys and Questionnaires
15.
J Pediatr Hematol Oncol ; 38(1): 27-31, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26422286

ABSTRACT

Iron overload is a significant cause of morbidity and mortality for patients who require frequent transfusions. We completed a prospective, cross-sectional study to evaluate the prevalence of iron overload in previously transfused childhood cancer survivors. Survivors recruited from the University of Minnesota Long-Term Follow-Up Clinic were stratified into 3 groups: oncology patients not treated with hematopoietic stem cell transplantation (HSCT) (n=27), patients treated with allogeneic HSCT (n=27), and patients treated with autologous HSCT (n=9). Serum ferritin was collected and hepatic magnetic resonance imaging (FerriScan) was obtained for those with iron overload (defined as ferritin ≥1000 ng/mL). The prevalence of iron overload in subjects with a history of allogeneic HSCT was 25.9% (95% CI, 9.4%-42.5%) compared with only 3.7% (95% CI, 0%-10.8%) in subjects treated without HSCT and 0% in subjects treated with autologous HSCT. No association was found between serum ferritin levels and the presence of cardiac, liver, or endocrine dysfunction. The prevalence of iron overload in subjects who received no HSCT or autologous HSCT is low in our study. A higher prevalence was found in patients receiving allogeneic HSCT, reiterating the importance of screening these patients for iron overload in accordance with the current Children's Oncology Group Long Term Follow-Up Guidelines.


Subject(s)
Hematopoietic Stem Cell Transplantation/adverse effects , Iron Overload/epidemiology , Neoplasms/therapy , Adolescent , Child , Child, Preschool , Cross-Sectional Studies , Female , Ferritins/blood , Hematopoietic Stem Cell Transplantation/methods , Humans , Infant , Infant, Newborn , Iron Overload/etiology , Male , Prevalence , Prospective Studies , Survivors , Transplantation, Autologous/adverse effects , Transplantation, Homologous/adverse effects , Young Adult
16.
J Pediatr Oncol Nurs ; 33(1): 64-73, 2016.
Article in English | MEDLINE | ID: mdl-25643973

ABSTRACT

Survivors of childhood cancer may experience persistent symptoms, including fatigue, sleep disturbance, and balance impairment. Yoga is a complementary therapy that improves fatigue, sleep, and quality of life in adult cancer survivors. Using a one group, repeated measures design, we evaluated the feasibility of a yoga program and assessed if cancer survivor participants ages 10 to 17 years (n = 13) had significantly less fatigue and anxiety, and better balance and sleep, after a 6-week yoga intervention compared with a 6-week pre-intervention wait period. Study recruitment was challenging with a 32% enrollment rate; yoga attendance was 90%. None of the scores for anxiety, fatigue, sleep, and balance had significant changes during the wait period. After the 6-week yoga program, children (n = 7) had a significant decrease in anxiety score (P = .04) while adolescent scores (n = 7) showed a decreasing trend (P = .10). Scores for fatigue, sleep, and balance remained stable post-intervention. Fatigue and balance scores were below norms for health children/adolescents while sleep and anxiety scores were similar to healthy peers.


Subject(s)
Anxiety/prevention & control , Fatigue/prevention & control , Neoplasms/psychology , Neoplasms/rehabilitation , Sleep Wake Disorders/prevention & control , Survivors/psychology , Yoga , Adolescent , Anxiety/etiology , Child , Fatigue/etiology , Feasibility Studies , Female , Humans , Male , Minnesota/epidemiology , Neoplasms/therapy , Quality of Life , Research Design , Sleep Wake Disorders/etiology , Treatment Outcome , Yoga/psychology
17.
Biol Blood Marrow Transplant ; 21(7): 1278-83, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25865649

ABSTRACT

Along with other childhood cancer survivors (CCS), hematopoietic cell transplantation (HCT) survivors are at high risk of treatment-related late effects, including cardiovascular disease and diabetes. Cardiometabolic risk factor abnormalities may be exacerbated by inadequate physical activity (PA). Relationships between PA and cardiometabolic risk factors have not been well described in CCS with HCT. PA (self reported), mobility (timed up and go test), endurance (6-minute walk test), handgrip strength, and cardiometabolic risk factors were measured in 119 HCT survivors and 66 sibling controls ages ≥18 years. Adjusted comparisons between HCT survivors and controls and between categories of low and high PA, mobility, endurance, and strength were performed with linear regression. Among HCT survivors, the high PA group had lower waist circumference (WC) (81.9 ± 2.5 versus 88.6 ± 3.1 cm ± standard error (SE), P = .009) than the low PA group, whereas the high endurance group had lower WC (77.8 ± 2.6 versus 87.8 ± 2.5 cm ± SE, P = .0001) and percent fat mass (33.6 ± 1.8 versus 39.4 ± 1.7% ± SE, P = .0008) and greater insulin sensitivity (IS) (10.9 ± 1.0 versus 7.42 ± 1.14 mg/kg/min ± SE via euglycemic insulin clamp, P = .001) than the low endurance group. Differences were greater in HCT survivors than in controls for WC between low and high PA groups, triglycerides between low and high mobility groups, and WC, systolic blood pressure, and IS between low and high endurance groups (all Pinteraction <.05). Higher endurance was associated with a more favorable cardiometabolic profile in HCT survivors, suggesting that interventions directed to increase endurance in survivors may reduce the risk of future cardiovascular disease.


Subject(s)
Cardiovascular Diseases/prevention & control , Hematologic Neoplasms/therapy , Hematopoietic Stem Cell Transplantation/adverse effects , Motor Activity , Survivors , Adult , Blood Pressure , Body Mass Index , Cardiovascular Diseases/blood , Cardiovascular Diseases/etiology , Cardiovascular Diseases/physiopathology , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Female , Hand Strength/physiology , Hematologic Neoplasms/immunology , Hematologic Neoplasms/pathology , Humans , Insulin Resistance , Male , Physical Endurance , Prospective Studies , Risk Factors , Siblings , Transplantation, Homologous , Triglycerides/blood , Waist Circumference
18.
Pediatr Blood Cancer ; 62(2): 305-310, 2015 02.
Article in English | MEDLINE | ID: mdl-25327738

ABSTRACT

BACKGROUND: Childhood cancer survivors (CCS) are at high risk of developing treatment-related late effects, including cardiovascular disease and diabetes. Late effects can be exacerbated by low physical activity (PA) levels. Relationships between PA and cardiovascular risk factors during childhood have not been well described in CCS. PROCEDURE: PA and cardiovascular risk factors were measured cross-sectionally in 319 CCS and 208 sibling controls aged 9-18 years. Comparisons between CCS and controls and associations of outcomes with PA (dichotomized at 60 min/day or treated as continuous) were performed with linear regression. RESULTS: Among CCS, the high PA group had lower percent fat mass (24.4% vs. 29.8%, P < 0.0001), abdominal subcutaneous fat (67.9 vs. 97.3 cm3 , P = 0.0004), and abdominal visceral fat (20.0 vs. 24.9 cm3 , P = 0.007) and greater lean body mass (41.3 vs. 39.5 kg, P = 0.009) than the low PA group. Comparing CCS to controls, differences in waist circumference (Pinteraction = 0.04), percent fat mass (Pinteraction = 0.04), and abdominal subcutaneous (Pinteraction = 0.02) and visceral (Pinteraction = 0.004) fat between low and high PA groups were greater in CCS than controls, possibly due to greater overall adiposity in CCS. CONCLUSIONS: High PA in CCS resulted in an improved cardiovascular profile, consisting primarily of lower fat mass and greater lean mass, similar to that observed in controls. This suggests interventions directed to increase PA in CCS may reduce the risk of future cardiovascular disease. Pediatr Blood Cancer 2015;62:305-310. © 2014 Wiley Periodicals, Inc.


Subject(s)
Adiposity/physiology , Cardiovascular Diseases/epidemiology , Exercise/physiology , Neoplasms/therapy , Obesity/physiopathology , Adolescent , Body Composition/physiology , Child , Cross-Sectional Studies , Female , Humans , Male , Risk Factors , Waist Circumference/physiology
19.
J Clin Oncol ; 31(22): 2799-805, 2013 Aug 01.
Article in English | MEDLINE | ID: mdl-23796992

ABSTRACT

PURPOSE: Childhood cancer survivors (CCSs) are at risk for physical disability. The aim of this investigation was to characterize and compare physical performance among CCSs and a group of siblings age < 18 years and determine if diagnosis, treatment, and physical activity levels were associated with lower performance scores. METHODS: CCSs ≥ 5 years from diagnosis and a sibling comparison group were recruited and evaluated for strength, mobility, and fitness. Physical performance measures were compared in regression models between survivors and siblings by diagnosis and among survivors by treatment exposures and physical activity levels. RESULTS: CCSs (n = 183; mean age ± standard deviation [SD], 13.5 ± 2.5 years; 53% male) scored lower than siblings (n = 147; mean age ± SD, 13.4 ± 2.4 years; 50% male) on lower-extremity strength testing, the timed up-and-go (TUG) test, and the 6-minute walk (6MW) test, despite reporting similar levels and types of habitual physical activity. The lowest scores were prevalent among survivors of CNS tumors and bone and soft tissue sarcomas on strength testing (score ± SD: CNS tumors, 76.5 ± 4.7; sarcoma 67.1 ± 7.2 v siblings, 87.3 ± 2.4 Newton-meters quadricep strength at 90° per second; P = .04 and .01, respectively) and among CNS tumor survivors on the TUG (score ± SD: 5.1 ± 0.1 v siblings, 4.4 ± 0.1 seconds; P < .001) and 6MW tests (score ± SD: 533.3 ± 15.6 v siblings, 594.1 ± 8.3 m; P < .001). CONCLUSION: CCSs may have underlying physiologic deficits that interfere with function that cannot be completely overcome by participation in regular physical activity. These survivors may need referral for specialized exercise interventions in addition to usual counseling to remain physically active.


Subject(s)
Motor Activity , Neoplasms/physiopathology , Adolescent , Child , Female , Humans , Male , Muscle Strength , Neoplasms/mortality , Neoplasms/therapy , Survivors
20.
J Obstet Gynaecol Can ; 35(5): 426-433, 2013 May.
Article in English | MEDLINE | ID: mdl-23756273

ABSTRACT

OBJECTIVE: To compare wound complications after Caesarean section in the obese patient, following early versus delayed skin staple removal. METHODS: We conducted a single-centre, non-inferiority, randomized controlled trial. Following Caesarean section, obese women (BMI ≥ 30 kg/m(2)) with subcutaneous wound depth ≥ 2.0 cm and skin staple closure of a transverse incision were randomized to staple removal on postoperative day 3 (early) or between postoperative day 7 and postoperative day 10 (delayed). The primary outcome was superficial wound dehiscence; a rate of 8% or higher in the early group was defined as inferior. Secondary outcomes were seroma/hematoma, surgical site infection, and visual analogue pain score. The planned sample size was 250 patients per group. RESULTS: The study was halted after 295 patients were randomized because of slow enrolment and exhaustion of funding. The rate of superficial wound dehiscence was 15.2% in the early group (n = 145) versus 11.5% in the delayed group (n = 148). The point estimate for this difference (3.7 %; 95% CI -4.4 to 12.4) favours delayed removal. However, because the 95% CI includes zero and the upper CI exceeds the predefined limit for non-inferiority (8%), non-inferiority was not demonstrated. The rates of all secondary outcomes were similar in the early group and the delayed group: seroma/hematoma (6.9% vs. 4.7%; RR 1.4, 95% CI 0.6 to 3.7, P = 0.4); surgical site infection (9.7% vs. 4.8%; RR 2.0, 95% CI 0.8 to 4.9, P = 0.1); and composite (superficial wound dehiscence, seroma/hematoma, and surgical site infection) wound complication (17.2% vs. 12.8%; RR 1.3, 95% CI 0.8 to 2.3, P = 0.3). CONCLUSION: The non-inferiority of early skin staple removal was not demonstrated. Delayed removal of staples should remain the accepted standard in the obese patient following Caesarean section.


Objectif : Comparer les effets du retrait précoce des agrafes cutanées aux effets de leur retrait différé, en ce qui concerne les complications de plaie à la suite d'une césarienne chez une patiente obèse. Méthodes : Nous avons mené un essai comparatif randomisé de non-infériorité au sein d'un seul centre. À la suite d'une césarienne, les femmes obèses (IMC ≥ 30 kg/m2) qui présentaient une profondeur de plaie sous-cutanée ≥ 2,0 cm et une incision transversale fermée au moyen d'agrafes cutanées ont été affectées, au hasard, à un groupe devant se faire retirer ces agrafes trois jours à la suite de l'opération (retrait précoce) ou à un groupe devant se faire retirer ces agrafes entre le septième jour et le dixième jour suivant l'opération (retrait différé). La déhiscence superficielle de la plaie constituait le critère d'évaluation principal; un taux de 8 % ou plus au sein du groupe « retrait précoce ¼ a été défini comme étant inférieur. Les critères d'évaluation secondaires étaient le sérome / hématome, l'infection du champ opératoire et le score sur l'échelle visuelle analogue. La taille planifiée de l'échantillon était de 250 patientes par groupe. Résultats : L'étude a été suspendue à la suite de la randomisation de 295 patientes, en raison de la lenteur du processus de sollicitation des patientes et de l'épuisement des fonds. Le taux de déhiscence superficielle de la plaie était de 15,2 % au sein du groupe « retrait précoce ¼ (n = 145) vs 11,5 % au sein du groupe « retrait différé ¼ (n = 148). L'estimation ponctuelle pour cette différence (3,7 %; IC à 95 %, −4,4 - 12,4) favorise le retrait différé. Toutefois, puisque l'IC à 95 % contient zéro et que l'IC supérieur dépasse la limite prédéfinie pour ce qui est de la non-infériorité (8 %), cette dernière n'a pas été démontrée. Les taux de tous les critères d'évaluation secondaires étaient semblables dans les deux groupes : sérome / hématome (6,9 % vs 4,7 %; RR, 1,4, IC à 95 %, 0,6 - 3,7, P = 0,4); infection du champ opératoire (9,7 % vs 4,8 %; RR, 2,0, IC à 95 %, 0,8 - 4,9, P = 0,1); et complication composite de la plaie (déhiscence superficielle de la plaie, sérome / hématome, infection du champ opératoire) (17,2 % vs 12,8 %; RR, 1,3, IC à 95 %, 0,8 - 2,3, P = 0,3). Conclusion : La non-infériorité du retrait précoce des agrafes cutanées n'a pas été démontrée. Le retrait différé des agrafes devrait demeurer la norme acceptée en ce qui concerne les patientes obèses à la suite d'une césarienne.


Subject(s)
Cesarean Section , Device Removal/adverse effects , Obesity/complications , Surgical Wound Dehiscence/etiology , Sutures/adverse effects , Adult , Female , Hematoma/etiology , Humans , Pain, Postoperative/etiology , Seroma/etiology , Surgical Stapling , Surgical Wound Infection/etiology , Time Factors , Young Adult
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